Angiographic and arteriographic catherters

ABSTRACT

An angiographic catheter through which material passes toward a tapered tip and which includes several series of discharge holes arranged in axially spaced radial planes, the total cross sectional area of the holes in each of said planes decreasing as the planes are placed closer to the tip, and which also includes a discharge chamber immediately adjacent the tip, there being a set of proximal holes also aligned in a radial plane and leading backwardly away from the chamber and a small end hole in the tip which also leads to the chamber, all of the holes being formed by punching them from the inside of the catheter outwardly.

l. States atent i 1 Spiroti 11] 3,828,767 Aug. 13, 1974 154]ANGHOGRAPHHC AND ARTERHOGRAPHIC CATHERTERS [75] Inventor: Carl M.Spiroff, Granite City, 111.

[73] Assignee: Joseph A. Fenton, .113, St. Louis County, Mo. a partinterest 22 Filed: 0ct.29, 1973 21 Appl. No.: 410,629

[52] US. Cl 128/2.05, 128/348, 128/349 R, 128/350 R, 128/351 [51] llnt.Cl. A6lm 25/00, A6lm 31/00 [58] Field of Search 128/2.05 R, 348, 349 R,128/349 B, 350 R, 351, DIG. 12; 131/15 B [56] References Cited UNITEDSTATES PATENTS 397,060 l/l889 Knapp 128/349 3 2,304,009 12/1942 Muth131/15 B 3,071,] 37 l/1963 Niebel et a1. 128/276 3,124,143 3/1964Bartolomeo 131/253 3,421,510 1/1969 Kettenbach.... 128/350 R 3,528,4279/1970 Sheridan 128/350 R Primary Examiner-Aldrich F. Medbery Attorney,Agent, or Firm-Joseph A. Fenton [5 7] ABSTRACT An angiographic catheterthrough which material passes toward a tapered tip and which includesseveral series of discharge holes arranged in axially spaced radialplanes, the total cross sectional area of the holes in each of saidplanes decreasing as the planes are placed closer to the tip, and whichalso includes a discharge chamber immediately adjacent the tip, therebeing a set of proximal holes also aligned in a radial plane and leadingbackwardly away from the chamber and a small end hole in the tip whichalso leads to the chamber, all of the holes being formed by punchingthem from the inside of the catheter outwardly.

13 Claims, 9 Drawing Figures Of the catheters manufactured today, thereappear to be none which are designed and constructed in such a manner asto make them ideal for angiographic use wherein the catheter is passedthrough a vein and into one of the major chambers of the heart. Whenplaced within the heart and used for angiographic and arteriographicpurposes, a catheter must have the following three properties: a

A. It must disperse its material within the cavity as a uniform, welldefined bolus at variable injection rates using a minimum of material;

B. It must make such dispersal in such manner that the inner tissues andlining of the heart are not damaged by either whipping or axialdisplacement of the catheter, or by the force of the stream of materialas it is dispersed; and

C. The catheter must be constructed in such manner that the dischargeports are free of burrs and particles of catheter material which couldenter the heart and cause an embolism reaction therewithin.

Urological catheters, which are the most common, fall short in all threeof the above requisites because of design and construction, and therenow exists an immediate need for catheters designed and constructedspecifically for angiographic usage and which have the above describedproperties.

It is the object of this invention to provide a catheter designed tosatisfy this need.

With the above and other objects in view which will become immediatelyapparent upon reading this application, my invention resides in theunique and novel form, construction, combination and assembly of thevarious steps and structures shown in the drawings, described in thespecification and claimed in the claims.

IN THE DRAWINGS FIG. 1 is a side view of my catheter immediately priorto forming the tip;

FIG. 2 is a similar view of the tip forming mandrel with the catheterend shown in phantom;

FIG. 3 is a sectional view of my outer tip forming mold;

FIG. 4 is the same view as FIG. 3 showing the mandrel and mold in theforming position and the catheter shown in phantom;

FIG. 5 is a sectional view of the formed tip;

FIG. 6 is a sectional view of the block and punch utilized to punchreverse ports of the formed tip;

FIG. 7 is a view of the completed tip;

FIG. 8 is a fragmentary sectional view taken along lines 88 of FIG. 7;and

FIGS. 9, l0 and 11 are sectional views taken along lines B-B, CC and DDrespectively of FIG. 7.

Referring now in more detail and by reference character to the drawings,A represents a catheter comprising a length of catheter tubing (usually1 meter in length) having an open end 22 with prepunched axially spacedsets of distal holes 24, 26 and 28. The holes 24 are equal to each otherin size and in radial registration about plane CC. Similarly, the holes26 are larger than the holes 24 and are also equal to each other in sizeand in radial registration about plane DD. Furthermore, the holes 28 arelarger than the holes 26 and are equal to each other in size and inradial registration about plane EE. It should be here noted that each ofthe planes CC, DD and EE are radial t0 the longitudinal axis of thecatheter A.

Provided for forming the tip 30 of the Catheter A, is a mandrel 32 andmold 34. The mandrel 32 comprises .an elongated flexible push wire 36sized in length for passage through the tubing 20 and provided on itsforward end with a diametrally reduced neck 38, an enlarged button-likehead 40 and a tip 42. The mold 34 comprises an elongated tubular shell44 terminated at one end with an outwardly flanged tip 46 and at theother end with a taper 48 provided with a bore 50 sized for acceptingthe tip 42 of the mandrel 32.

The tip 30 is formed by inserting the mandrel 32 in the tube A as seenin FIG. 2 in such manner that the head 40 is nestedly disposedtherewithin at the end of the tubing 20 and the tip 42 projectsoutwardly therefrom. Thereafter the mold 34 is heated and the tubing 20and mandrel 32 are urged into the heated mold 34 and allowed to cool.After sufficient time has elapsed for the material of the tubing 20 toconform tojthe shape of the mandrel 32 and the mold 34 and thereaftercool, the mold 34 is removed and the mandrel 32 is popped out of thetubing 20.

After the tip forming process is completed, the tip 30 of the catheter Awill have an outer taper 54 and an inner neck 56, a diametricallyreduced end hole 58, and a diametrically enlarged chamber therebetween.

The catheter A is completed by punching proximal holes 62 in the tip 30.This is accomplished by using a jig 64 and a punch 66. The jig 64comprises a block 68 of material provided at one end with a tapered bore70 sized for snug-fitting nested disposition about the tip 30. The depthof the bore 70 is such that the end 72 of the block 66 will lie inregistration with the slots 26 for purposes presently more fully toappear. The jig 64 also includes a guide bore 74 sized for accepting thetip 76 of the punch 66 and guiding the same through the end hole 58 andthe chamber 60 through the wall of the catheter 20 to punch one hole 62.Ideally, the jig 64 is provided with opposing recesses 78, 80 toaccommodate the handle 82 and the tip 76 of the punch 66. The core ofthe punch 66 is hollow so that as the hole 62 is punched, the cathetermaterial which is removed becomes imbedded in the hollow portion of thetip 76. Slidably disposed in the hollow portion of the punch 66 is amaterial ejection pin 84 which may be utilized to eject the catheterslug 88 removed in the punching of the hole 62, as best seen in FIG. 6.

Since, as will be pointed out later, registration of alternating sets ofholes is important to the operation of my invention, the end of the jig64 is provided with a notch 90 (or other suitable indicia means) topermit the registration of the proximal holes 62 as they are punched andthe holes 26, and to cause the proximal holes 62 to lie in plane 8-8which is parallel to and spaced from planes CC, DD and EE. It should bealso noted that the holes 62 are directed rearwardly away from the endhole 58 for purposes presently more fully to appear.

LOCATION AND SIZING OF THE PERIPHERAL SLOTS The location, direction andsizing of the holes 62, 24, 26 and 28 is the most critical to thesuccessful operation of my catheter for angiographic purposes. Suchlocation and sizing has been determined as a combined result ofengineering study and clinical test. These holes have been designed andpositioned in such manner as to produce quickly a bolus of uniformdensity about the end of the catheter with minimal displacement of thecatheter in the heart cavity and without any high pressure jets ofmaterial emerging therefrom, or, more simply put, a cloud of uniformdensity within the cavity about the end of the catheter.

To accomplish this the peripheral holes 24, 26 and 28 are arranged inperipheral spray planes C-C DD and E-E which compliment proximal holesspray plane 8-8 and the end hole 58. It has been found that dispersionof the material is best accomplished using four sets of uniformly spaceddistal holes 24, 26 and 28 in each of the planes C-C, DD and E-Erespectively, with the holes 24 and 28 being in axial registration andthe holes 26 being angularly displaced by 45 from the registered holes24 and 28.

As the material moves through the catheter toward the tip 30, thematerial will first pass plane E-E and the holes 28 associatedtherewith. It should be noted that these holes 28 present the largesttotal opening. At plane E-E, some of the material will be urged throughthe holes 28 and the remainder of the material will proceed toward thetip 30 at slightly slower velocity but slightly increased pressure. Asthe undispersed material passes plane D-D and the holes 26 associatedtherewith, the combination of increased pressure and decreased totalopening presented by the holes 26 will cause approximately the sameamount of material to be dispersed through the holes 26 and theremainder of the material to continue proceeding toward the tip 30 underconditions of even slower velocity and increased pressure. Similarly,approximately the same amount of material will be dispersed through theholes 24, and the balance of the material will proceed through thecatheter and into the chamber 60 under even slower velocity and higherpressure. Once the material enters the chamber 60, it will be dispersedevenly out the proximal holes 62 and the end hole 58 under low velocityin the form of a cloud. Thus it should be apparent that the placement ofeach set of the holes 24, 26, 28 is such that there is no resultantradial forces to cause whipping, and the proximal holes 62 beingdirected away from the chamber 60 in a direction opposite the directionof flow through the end hole 58, there are no resultant axial forces tocause axial movement of the catheter within the heart as material isdispersed.

One final item should be noted. In order to acquire the optimumangiographic catheter, it is necessary to form the holes 62, 24, 26 and28 by punching them from the inside out as shown herein with regard tothe holes 62. This technique produces a catheter which is completelysmooth on the inside, and in which any burrs or irregularities are onthe external surface where such burrs and irregularities may be removedby abrading, or other similar procedures. The resultant catheter is onein which the exposure to the danger of embollismic reactions due to thepresence of foreign materials being introduced into the heart has forall practical purposes been eliminated.

Although the sets of holes 24, 26 and 28 have been shown as beingequiangularly spaced with respect to each other for producing clouds ofuniform density, various other configurations may be used provided thateach hole used is complimented by an axially opposed hole to balance theforces and to eliminate the possibility of whipping.

Toward this end I have developed a special hole punching tool forpunching the holes 24, 26, 28 which is the subject of a separate patentapplication being filed contemporaneously herewith.

It should be apparent that changes, alterations, substitutions andmodifications in the various arrangement, combination, configuration,and steps described herein may be made without departing from the natureand principle of my invention.

Having thus described my invention, what I claim and desire to secure byLetters Patent is described in the following Claims.

1. An angiographic catheter including an elongated tube provided at oneend with a tapered tip and means for discharging a bolus of fluid ofuniform density adjacent the tip,

including a plurality of sets of peripheral discharge openings in thetube, each set being longitudinally spaced from each other set,

each set of openings comprising a plurality of openings in radialregistration,

and the cumulative amount of open area in one set of discharge openingsbeing greater than the cumulative amount of open area in the set ofdischarge openings next closet to the tip.

2. The catheter of claim 1 in which the discharge openings in each setare equiangularly spaced with respect to each other.

3. The catheter of claim 1 in which the discharge openings in each setare equiangularly spaced with respect to each other and there are atleast four discharge openings in each set.

4. The catheter of claim 3 in which the discharge openings in everyother set of discharge openings are in registration along imaginarylines which are parellel to the longitudinal axis of the tube.

5. The catheter of claim 5 in which each discharge opening is in theshape of an elongated slot with rounded corners.

6. A catheter comprising an elongated tube provided at one end with atapered tip having a small centrally located end hole, said tip alsobeing provided internally with a narrow neck which is spaced from theend hole to define a chamber between the neck and the end hole, said tipalso including a plurality of openings located adjacent the tiprearwardly of the end hole and in communication with the chamber, saidtube also being provided rearwardly of the neck with a plurality of setsof distal openings, each of such sets comprising a plurality ofsimilarly sized openings in radial registration and each set beingaxially spaced longitudinally along the tube from each other set, thesize of the distal openings in each set being larger than the size ofthe distal openings of the other sets closer to the tip but smaller thanthe size of the distal openings of the sets farther from the tip.

7. The catheter of claim 6 in which each of the discharge openings insaid chamber is constructed in such manner as to direct the outward flowof the contents of the chamber away from the tip in a directionsubstantially opposite to the direction of flow through the end hole.

8. The catheter of claim 7 in which there are at least four dischargeopenings.

9. The catheter of claim 7 in which there are at least four dischargeopenings and each of the openings are in radial registration andequiangularly spaced.

10. The catheter of claim 6 in which there are the same number of distalopenings in each set and the distal openings in each set are regularlyspaced with respect to each other.

11. The catheter of claim 10 in which the distal openings of every otherset are in registration along imaginary lines which are parallel to theaxis of the tube.

12. The catheter of claim 10 in which the distal openings of every otherset are in registration along imaginary lines which are parallel to theaxis of the tube and the distal openings of the sets therebetween arelocated centrally between the adjacent distal openings of the nextclosed set.

13. An angiographic catheter for transmitting material, said cathetercomprising an elongated tube and means for balancing hydraulic dischargeforces therefrom to prevent whipping and axial movement of said cathetertube during said discharge including, a plurality of forwardly andrearwardly axially directed distal discharge holes located near one endof said tube and also being provided with a tapered tip at said end,said distal holes being located about the longitudinal axis and in thetip of the tube preselectively sized and directed in such manner thatthe sum of the radial forces created by the discharge of the materialthrough the distal holes is substantially zero.

1. An angiographic catheter including an elongated tube provided at oneend with a tapered tip and means for discharging a bolus of fluid ofuniform density adjacent the tip, including a plurality of sets ofperipheral discharge openings in the tube, each set being longitudinallyspaced from each other set, each set of openings comprising a pluralityof openings in radial registration, and the cumulative amount of openarea in one set of discharge openings being greater than the cumulativeamount of open area in the set of discharge openings next closet to thetip.
 2. The catheter of claim 1 in which the discharge openings in eachset are equiangularly spaced with respect to each other.
 3. The catheterof claim 1 in which the discharge openings in each set are equiangularlyspaced with respect to each other and there are at least four dischargeopenings in each set.
 4. The catheter of claim 3 in which the dischargeopenings in every other set of discharge openings are in registrationalong imaginary lines which are parellel to the longitudinal axis of thetube.
 5. The catheter of claim 5 in which each discharge opening is inthe shape of an elongated slot with rounded corners.
 6. A cathetercomprising an elongated tube provided at one end with a tapered tiphaving a small centrally located end hole, said tip also being providedinternally with a narrow neck which is spaced from the end hole todefine a chamber between the neck and the end hole, said tip alsoincluding a plurality of openings located adjacent the tip rearwardly ofthe end hole and in communication with the chamber, said tube also beingprovided rearwardly of the neck with a plurality of sets of distalopenings, each of such sets comprising a plurality of similarly sizedopenings in radial registration and each set being axially spacedlongitudinally along the tube from each other set, the size of thedistal openings in each set being larger than the size of the distalopenings of the other sets closer to the tip but smaller than the sizeof the distal openings of the sets farther from the tip.
 7. The catheterof claim 6 in which each of the discharge openings in said chamber isconstructed in such manner as to direct the outward flow of the contentsof the chamber away from the tip in a direction substantially oppositeto the direction of flow through the end hole.
 8. The catheter of claim7 in which there are at least four discharge openings.
 9. The catheterof claim 7 in which there are at least four discharge openings and eachof the openings are in radial registration and equiangularly spaced. 10.The catheter of claim 6 in which there are the same number of distalopenings in each set and the distal openings in each set are regularlyspaced with respect to each other.
 11. The catheter of claim 10 in whichthe distal openings of every other set are in registration alongimaginary lines which are parallel to the axis of the tube.
 12. Thecatheter of claim 10 in which the distal openings of every other set arein registration along imaginary lines which are parallel to the axis ofthe tube and the distal openings of the sets therebetween are locatedcentrally between the adjacent distal openings of the next closed set.13. An angiographic catheter for transmitting material, said cathetercomprising an elongated tube and means for balancing hydraulic dischargeforces therefrom to prevent whipping and axial movement of said cathetertube during said discharge including, a plurality of forwardly andrearwardly axially directed distal discharge holes located near one endof said tube and also being provided with a tapered tip at said end,said distal holes being located about the longitudinal axis and in thetip of the tube preselectively sized and directed in such manner thatthe sum of the radial forces created by the discharge of the materialthrough the distal holes is sUbstantially zero.